Nicotine Recall: Aveva Patch 14 mg
Announced 2026-06-03 · FDA
FDA recall for Aveva Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Lot 56841, expiration 03/2028, distributed nationwide in the U.S. The recall is due to elevated levels of oxidative-related impurities exceeding shelf-life specifications during stability testing of individual units. A total of 59,808 pouches (4,272 IFC) are affected.
| Brand | AVEVA Drug Delivery Systems, Inc. |
|---|---|
| Product | Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88. |
| Reason | Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units. |
| Severity | low |
| Units affected | 59808 |
| Distribution | Nationwide within the U.S |
| Agency | FDA |
| Recall / campaign no. | Lot #: 56841, Expires: 03/2028 |
WHAT YOU SHOULD DO
- If you have patches from Lot 56841, stop using them immediately.
- Contact Rugby Laboratories for return/disposal instructions and follow FDA recall updates.
- Keep the packaging and product information for reference until the recall is resolved.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.